# K112263: Monopolar Curved Scissors Tip Cover Accessory

- Pathway: 510(k) (Special)
- Applicant: Intuitive Surgical, Inc.
- Decided: Oct 7, 2011 after 60 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K930667 (1994). 53 ancestors in all.
27 later devices descend from it; 2 cite it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050005: Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model 400180, Intuitive Surgical, Inc. (2005) Summary page 1.
- K090993: Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000, Intuitive Surgical, Inc. (2009) Summary page 1.

## Most influential descendants
- K131962: DA Vinci SP Surgical System, Endowrist SP Instruments, and Accessories (2014), 22 descendants of its own
- K173906: da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories (2018), 21 descendants of its own
- K182371: da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories (2019), 20 descendants of its own
- K202571: da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories (2020), 14 descendants of its own
- K230033: Da Vinci SP Surgical System (SP1098) (2023), 12 descendants of its own

## Recalls of this device
- Aug 9, 2012 · Class II · Z-2339-2012: There is potential for the sterility of the product to be compromised.

## Indications for use
The Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Models 1S1200, 1S2000, IS3000) are intended to assist in the accurate control of Intuitive Surgical Endloscopic EndloWrist Instruments and Accessories including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic/harmonic shears; forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as Ti and T2, general thoracoscopic surgical procedures, and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Instructions for Use.

Source page: https://510kreport.com/device/K112263
Methodology: https://510kreport.com/methodology